Boehringer Ingelheim (BI) has commenced a Phase III clinical trial (DAREON-Lung-1) for its CD3×DLL3 bispecific T-cell engager (TCE), obrixtamig, in extensive-stage small cell lung cancer (ES-SCLC). The randomised, open-label study will enrol approximately 670 patients to evaluate the efficacy and safety of obrixtamig in combination with the standard-of-care regimen of atezolizumab, carboplatin and etoposide, compared to standard care alone. The primary endpoint of the trial is overall survival (OS).

Obrixtamig is the second CD3×DLL3 bispecific antibody (BsAb) to enter Phase III development, following Amgen/BeOne's approved drug tarlatamab. Early-phase data for obrixtamig, both as a monotherapy and in combinations, have shown encouraging response rates in previously treated SCLC patients.

PharmCube's NextBiopharm® database lists 17 CD3×DLL3 BsAbs in development globally, with only four past the preclinical stage. Click here to request a free trial for NextBiopharm®.